Digital Health Technologies (DHTs) for Drug Development
Digital Health Technologies (DHTs) for Drug Development
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Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by -
CDER Conversation: Novel Excipient Review Pilot Program
FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) -
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process
The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development. -
Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/27/2025
Short Title (70 char) Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
FEI Number 3013927023
Firm Name Apollo Care LLC
Record Type 483
State MO
Establishment Type Outsourcing Facility -
MHRA Safety Roundup: July 2025
Summary of the latest safety advice for medicines and medical device users
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Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
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Standard: Statement of Policy Intent: Early Access to Innovative Medical Devices
The MHRA’s initial plans on an Early Access service, which will be developed further throughout 2025.
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MHRA outlines intent to speed up patient access to innovative medical devices
Statement of Policy Intent sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs.
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High Noon Announces Recall of its Vodka Seltzer Beach Pack (12 Pack) Due to Inclusion of CELSIUS® ASTRO VIBE ™ Energy Drink Cans that were Inadvertently Filled with Vodka Seltzer
MODESTO, CA, July 29, 2025 – High Noon is recalling two production lots of High Noon Beach Variety packs (12-pack/12 fluid ounce cans). Some of these packs contain cans that are filled with High Noon vodka seltzer alcohol and are mislabeled as CELSIUS® ASTRO VIBE™ Energy Drink, Sparkling Blue Razz E -
Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process. -
Consumer Updates
Science-based health and safety information you can trust.